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MORPHEUSV for Overactive Bladder in Women

This study is testing a new vaginal device called MORPHEUSV for women with overactive bladder (OAB). OAB can cause a strong, sudden need to urinate and accidental urine leakage (urge urinary incontinence or UUI). The MORPHEUSV device uses radiofrequency (RF) energy, delivered in a single session without anesthesia, to help improve bladder control. Researchers want to see if MORPHEUSV can reduce UUI episodes by at least 50% compared to a sham (inactive) treatment. They also want to learn how safe it is. You might be able to join if you are a woman between 22 and 80 years old, have had OAB symptoms for at least 6 months, and experience at least 7 UUI episodes over 3 days.

Study design
This is a randomized, double-blind study comparing the MORPHEUSV device to a sham treatment. About 202 women will participate across multiple sites.
What's involved
You will receive one session of either the MORPHEUSV or sham treatment. Your UUI episodes will be tracked using a 3-day bladder diary.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure the reduction in UUI episodes 6 months after your treatment.

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NCT07209397

Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women

Recruiting
NAAges 22–80InterventionalTreatment
InMode MD Ltd.
~202 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:Detrusor nerve radiofrequency ablationSimulated (sham) detrusor nerve radiofrequency ablation

At a glance

Recruiting sites
5 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes
Measured over 6 months post-treatment

Conditions

Overactive Bladder
Overactive Bladder (OAB)
Urge Urinary Incontinence
Mixed Urinary Incontinence (Urge-Predominant)
Mixed Urinary Incontinence
Idiopathic Overactive Bladder With Urinary Incontinence
Idiopathic Overactive Bladder

Explore related trials

Mixed urinary incontinenceOveractive BladderUrge incontinence of urine

Where it's being run

9 sites across 9 states
California1
District of Columbia1
Idaho1
Illinois1
Kansas1
Massachusetts1
Nebraska1
Nevada1

Study leadership

  • Mickey Karram, MD · STUDY_DIRECTOR · Foundation for Female Health Awareness

Who to contact

FFHA Study Manager
[email protected]
573-300-9185
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female, aged 22 to 80 years inclusive at the time of consent.
History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.
At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.
Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.
Willing and able to complete the 3-day bladder diary.
Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.
Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.
Negative pregnancy test at screening (if applicable).
Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.

Exclusion

Predominant stress urinary incontinence (SUI) based on bladder diary
Currently pregnant, breastfeeding, or planning pregnancy during the study
History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)
Active urinary tract infection (UTI) at screening
History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain
Prior or current bladder cancer, pelvic malignancy, or pelvic radiation
Pelvic organ prolapse beyond the hymen (POP-Q stage \> II)
Implanted neuromodulation device or prior sacral nerve stimulation
Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months
Prior pelvic floor RF treatment or laser vaginal rejuvenation
Significant pelvic anatomical abnormalities that interfere with treatment
Use of investigational drug or device within 30 days before screening
Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity
Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)
Inability or unwillingness to comply with study requirements or follow-up

What this trial measures

  • Proportion of participants achieving ≥50% reduction in weekly urge urinary incontinence (UUI) episodes6 months post-treatment

    The percentage of participants who achieve at least a 50% reduction from baseline in the number of UUI episodes per week, as recorded in a 7-day bladder diary. This is the primary efficacy endpoint used to evaluate the effectiveness of the MORPHEUSV device compared to sham.